Statistical tools and control of internal lubricant content of inhalation grade HPMC capsules during manufacture

Int J Pharm. 2016 Apr 30;503(1-2):36-40. doi: 10.1016/j.ijpharm.2016.02.017. Epub 2016 Feb 18.

Abstract

The internal lubricant content (ILC) of inhalation grade HPMC capsules is a key factor to ensure good powder release when the patient inhales a medicine from a dry powder inhaler (DPI). Powder release from capsules has been shown to be influenced by the ILC. The characteristics used to measure this are the emitted dose, fine particle fraction and mass median aerodynamic diameter. In addition the ILC level is critical for capsule shell manufacture because it is an essential part of the process that cannot work without it. An experiment has been applied to the manufacture of inhalation capsules with the required ILC. A full factorial model was used to identify the controlling factors and from this a linear model has been proposed to improve control of the process.

Keywords: Aerosolization; Dry powder inhaler (DPI); HPMC capsules; Internal lubricant; Linear models.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Inhalation
  • Capsules / chemistry*
  • Chemistry, Pharmaceutical
  • Dry Powder Inhalers*
  • Hypromellose Derivatives / chemistry
  • Lubricants / chemistry*
  • Models, Statistical*
  • Oleic Acids / chemistry

Substances

  • Capsules
  • Lubricants
  • Oleic Acids
  • methyl oleate
  • Hypromellose Derivatives